The Union ministry of health is learnt to have sought a proposal from the Central Drug Standard Control Organization in a bid to open up the retail marketing of non- prescription drugs mainly from Schedule G drugs to general and non-medical stores in the country.

The proposal, which will lead to an extension of the current restricted licensing provision for the household medicines and the Schedule K of the Drugs & Cosmetics Act, which deals with exemption of drugs from trade license.

Schedule G drugs, which do not necessarily need a prescription to buy it from retail medical shop, are almost treated as over-the-counter drugs now. Though the rule insists the manufacturers to put the label to caution the patient as "the drug required to be taken under medical supervision," these can be purchased over the counter without a prescription. There are around 50 drugs in India put into the category of Schedule G.

The restricted licensing provision allows the drugs known as 'household medicines' to be sold in a shop where a qualified person/pharmacist is not required for dispensing the drug. Hence, if this provision can be extended to majority of the OTC products like cough and cold preparations, pain management tablets/creams, vitamin and mineral products, health supplements etc can be allowed to be kept and sold at any shops without an exclusive drug trade license and other required conditions.

According to sources at CDSCO, the Drug Controller General of India (DCGI) had convened a meeting of the drug control officials and the drug experts to make consensus in this regard. However, no serious decision has been taken on the same as the officials were divided over the subject, as the drug awareness among the people is a major concern in the country.

At the same time, the industry sources said that, there were resistance from the CDSCO and also from the Health ministry to open up the market for OTC products, currently the government is thinking over similar line seriously by extending the scope of restricted licensing and providing exemptions for more drugs under Schedule K.

However, looking at the expanded market reach of OTC drugs once the government makes these amendments in the rule, there are number of drug companies aggressively planning exclusive OTC divisions to promote their products with consumer marketing strategies.